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Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

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ClinicalTrials.gov Identifier: NCT03578380
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
University of Oslo
Ohio State University
Information provided by (Responsible Party):
Sykehuset Telemark

Brief Summary:
A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.

Condition or disease Intervention/treatment Phase
Secondary Lymphedema Breast Cancer Procedure: Surgery Other: Compression and drainage therapy Not Applicable

Detailed Description:
This is a randomized study comparing lymphovenous anastomosis versus conservative (compression) treatment for lymphoedema after breast cancer surgery - 50 patients to be included in each study arm. The primary endpoint is volume change measured by submersion and changes in arm circumference at defined levels from the wrist. Secondary endpoint is health related quality of life measured by questionnaire Short Form 36 (SF-36), Hospital Anxiety Depression Score (HADS), Fatigue Questionnaire (FQ) and a disease-specific questionnaire, Upper Limb Lymphedema score (ULL27).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.
Actual Study Start Date : January 26, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgery
Lymphovenous anastomosis
Procedure: Surgery
Lymphovenous anastomosis

Active Comparator: Compression
Conservative treatment with physiotherapy and compression
Other: Compression and drainage therapy
Treatment with compression stockings and manual drainage (massage therapy)




Primary Outcome Measures :
  1. Volume [ Time Frame: 12 months ]
    Volume of arm as described by submersion and circumference measures


Secondary Outcome Measures :
  1. Health related quality of life ULL27 [ Time Frame: 12 months ]

    To be measured by questionnaire "Upper Limb Lymphedema score 27" (ULL27) by Professor Robert Launois at REES France. The scale measures health related quality of life in patients with upper limb lymphedema.

    Construction: 27 questions rated from 1 (lowest quality of life) to 5 highest quality of life.

    Dimensions: There are 3 dimensions assessing symptoms, self value, everyday social life. Total score 27-135 Symptom score: 18-90 Self value: 5-25 Social life: 4-20 Question 20 and 22 are part of the self value dimension and are control questions with reverse scores, i.e 1 represents highest quality of life and 5 represents lowest quality of life. The scores for question 20 and 22 are later reversed when adding the total score.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral lymphedema of the arm secondary to breast cancer treatment. Stage 1-3 operable lymphedema.

Exclusion Criteria:

  • Frequent or severe cellulitis. All other lymphedema.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578380


Contacts
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Contact: Lars Johan Sandberg, MD +4735003456 johansandberg@hotmail.com

Locations
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Norway
Sykehuset Telemark Recruiting
Skien, Telemark, Norway, NO-3710
Sponsors and Collaborators
Sykehuset Telemark
University of Oslo
Ohio State University
Investigators
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Principal Investigator: Lars Johan Sandberg, MD Sykehuset Telemark

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Responsible Party: Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT03578380     History of Changes
Other Study ID Numbers: Prosjektnr 1097.19
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sykehuset Telemark:
Lymphovenous bypass
Lymphovenous anastomosis
Supermicrosurgery
Lymphangiography
MD Anderson Lymphedema Stage
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases